L6 (+ some L5 Content) Flashcards
What are the GMP & Safety concerns of nanomedicines?
Nanoparticles released into the environment during manufacture are potential:
- Health hazards
- Cross-contamination hazard
What are the benefits of QbD (quality by design) and PAT (Process Analytical Technologies)?
Note: All which can contribute towards moving towards continuous manufacturing from traditional batch manufacturing (5)
- Non-destructive (Testing under QbT can lead to destruction)
- Higher quality assurance of entire batch
- Real time release of products
(E.g. Parametric Release of Batch Sterilized products using validated terminal sterilisation methods allows terminally sterilised parenterals to be released, instead of being delayed and subjected to testing for sterility)
- Reduction in post-approval submissions to regulator
- Cost savings for the industry
How to remember: QbD and PAT brings benefits that is similar to when a firm experiences economies of scale
What are the challenges of implementing QbD/PAT?
Hint: Experienced by both Regulators and Manufacturers
- Limited understanding of QbD/PAT by manufacturers and even regulators
- High financial investment (initially)
- Industries - Old habits die hard (Difficult to get manufacturers to change)
- Regulators are not ready for QbD/PAT submissions; to carry out inspections catered for QbD-based Manufacturing
What is the main benefit of continuous manufacturing?
Definition: Continuous production is a flow production method used to manufacture, produce, or process materials without interruption.
Main Benefit : Cost savings
- Fewer steps and manual handling
- Higher quality assurance
- Non-destructive (conventional manufacturing can be destructive especially during testing)
- Real time release of finished products
- Saves warehouse space
- Shorter batch processing time
What is the biggest hurdle for taking up Continuous Manufacturing?
(A) The science for Continuous Manufacturing does not yet exist
(B) Experience is lacking from manufacturers and regulators
(C) There are regulatory hurdles
B - Experience is lacking from manufacturers and regulators
Technology for Continuous Manufacturing well exists, and there are no regulatory hurdles (In fact, regulators encourage QbD among manufacturers)
Excipients are inert substances that are combined with the active pharmaceutical ingredients to form a finished product.
T/F?
False.
Excipients may NOT be inactive or inert!
What are the benefits of Single Use Technologies (SUT)?
- Higher level of Quality Assurance
- Enhanced level of containment
- Enhanced cross contamination control - Savings of time and cost
- Flexible manufacturing requiring less space
- Cost and time savings in terms of maintenance (e.g. regular cleaning and servicing)
Name and define what is PAT?
Process Analytical Technology
- Design, analyze, and control pharmaceutical manufacturing processes through the determination/measurement of critical process parameters (CPPs) which affect critical quality attributes (CQA)
CPP affects CQA
CPP: CPPs are attributes that are monitored to detect deviations in standardized production operations and product output quality or changes in critical quality attributes (e.g. Speed of Tablet Compression, etc.)
CQA: Critical quality attributes (CQA) are chemical, physical, biological and microbiological attributes that can be defined, measured, and continually monitored to ensure final product outputs remain within acceptable quality limits. (e.g. Homogeneity and stability of the finished dosage form)
What is ASEAN MRA?
ASEAN Mutual Recognition Agreements
What is LIS?
Listed Inspection Services
When was the ASEAN MRA signed?
10 April 2009
What pharmaceutical products does the ASEAN MRA cover?
Currently, only Medicinal Products in Finished dosage forms for the current ASEAN Sectoral MRA
The scope of the MRA will be expanded to include the manufacture of APIs and Biologicals
What are the benefits of the ASEAN MRA on GMP Inspection?
- Avoid duplication of GMP audits within ASEAN
- Save time, resources & costs for regulators and industry
- Facilitates trade in medicinal products across ASEAN
- Quicker access of medicinal products by ASEAN patients
- Harmonising ASEAN Inspection System to that of PIC/S
- Increased attractiveness of ASEAN to investors from China, Japan, Korea, US, EU and other large economies.
Who are the current countries that are in the register of Listed Inspection Services (LIS)?
Singapore Malaysia Indonesia Thailand Philippines (as of 2 January 2020)
What are some future ASEAN developments and collaborations?
- Increase number of ASEAN LIS (Recently, Philippines joined as the 5th LIS)
- Train & continually train ASEAN inspectors
- Expand scope of ASEAN sectoral MRA → Include manufacture of APIs & biologics by November 2020 (Important)
- APIs AND Biologics ! - Connecting ASEAN with Asia & rest of the world
